Introducer device

ABSTRACT

An introducer and method provides a surgical tool with a pathway through tissue to a surgical site, wherein the surgical tool includes at least one surgical instrument. The introducer comprises a flexible sheath having a distal portion including a distal end and is arranged for receiving the surgical tool. A tissue separation tip at the distal portion of the sheath advances the sheath into the tissue towards the surgical site. The tissue separation tip is arranged to form a tissue gap and provide the at least one surgical instrument access to the tissue gap for performing a medical procedure consonant with the formation of the tissue gap or the performance of work at the surgical site.

PRIORITY CLAIM

This application is a Divisional of U.S. patent application Ser. No.13/051,888, filed Mar. 18, 2011, which claims the benefit of U.S.Provisional Patent Application No. 61/315,018, filed Mar. 18, 2010, thecontents of each of which are incorporated by reference in theirentirety.

BACKGROUND OF THE INVENTION

The present invention is directed to a surgical device. The presentinvention is more particularly directed to an introducer for providing asurgical tool with a pathway to a surgical site. The present inventionis still more particularly directed to such an instrument for use withsurgical devices for robotic surgery, such as for example, roboticneurosurgery.

Surgery has typically involved obtaining access to a region that exposesmany aspects of a lesion (e.g. tumor, aneurysm, etc.) allowing itstreatment or complete dissection and removal. However, obtaining accessto the lesion may also involve damage to areas of the brain or othertissues that are normal. In view of the foregoing, a movement hasdeveloped to perform what is called “Minimally Invasive Surgery.”Unfortunately, this, in many instances, is a misnomer since the surgerymay or may not be “minimally invasive” both to the critical tissuesunder consideration, but also to collateral tissues at the site of entryor along the access path. A better term for this type of surgery is“Minimal Access Surgery.” Examples of such surgery include: EndoscopicSurgery, Endoscope Assisted Surgery, Endovascular Surgery, StereotacticRadiosurgery, etc.

It is often necessary to treat brain tumors and aneurysms in the base ofthe skull. These are very difficult to treat because accessing the skullbase requires disruption of many important structures. It is desirableto minimize the size of any opening to be made through the skull andsurrounding, healthy tissues so that pathology in the skull base istreated with the least amount of potential damage to surroundingtissues. Such a procedure could be thought of as “Minimally DisruptiveSurgery.” Current endoscopic and endoscope-assisted operations performedon the head, skull base, chest, abdomen, and other areas are done withrigid and straight endoscopes and tools that can only work in a straightline. However, in complex areas such as the brain, the endoscope has tonegotiate many obstacles en route (e.g. bone, brain, and blood vessels).This imposes significant restrictions on the surgery being performed andcan lead to an increase in collateral tissue damage, due to enlargingthe access path and/or damaging or sacrificing the control over thestructures near the lesion. Additionally, there are certain types ofsurgery that are at present not possible given the limitations posed byexisting technology.

On the other hand, today's endovascular surgery is often performed overcomparatively great distance, and by navigating through a variety ofcurved channels. Such surgery uses a system of coaxial tubes andactuation cables that work on the basis of forward and backwardmovement, and side-to-side movement. Such devices are used withreal-time imaging that guides the operator to the target. A similarapproach is used with flexible endoscopes that work inside thegastrointestinal tract. However, these methods are not applicable formicro scale surgeries, as are performed for intricate neurosurgeries.

In addition to the foregoing, it is sometimes desirable during surgicalprocedures to irrigate a surgical site, clean surgical tools, orrepeatedly remove and reintroduce surgical tools. This presents aproblem with currently known robotic surgical systems because removal ofthe entire system is generally required to change tools.

In answer to the short comings and problems associated with the surgicaltools mentioned above, a new and improved surgical device has been underdevelopment. This device is shown and described, for example, inco-pending application Ser. No. 12/943,745 (our 2915-001-03) filed Nov.10, 2010, for SURGICAL DEVICE, which application is incorporated hereinin its entirety. The surgical device describe therein is a surgicaldevice capable of steering surgical tools to surgical sites overcurvilinear neurosurgery paths to avoid unnecessary damage to sensitiveor critical collateral tissue. The device is capable of steeringsurgical tools around anatomical obstacles while affording the toolscomplete maneuverability at the surgical site and removal/replacementduring neurosurgical procedures.

While such a device represents a significant step forward forneurosurgical applications, the advancement would not be realized unlessthe surgical device could be delivered to the intended surgical sitewithout causing damage to other tissue. What is thus required is anintroducer that is capable of creating a working space for the surgicalinstrument by retracting adjacent tissue without causing undue trauma.For example, in neurosurgery, the introducer would need to be able toseparate brain tissue from dura mater to create a channel to introducethe surgical tool. The tissue displacement must be both active andgentle. The introducer should desirably permit the surgical tools to beused during the surgical tool advancement procedure for visualization,connective tissue cutting and cauterizing in creating the instrumentpathway and eventual surgical site. The present invention is directed tothese and other issues.

SUMMARY

The invention provides an introducer for providing a surgical tool witha pathway through tissue to a surgical site, wherein the surgical toolincludes at least one surgical instrument. The introducer comprises aflexible sheath having a distal portion including a distal end and isarranged for receiving the surgical tool. The introducer furthercomprises a tissue separation tip at the distal portion of the sheathfor advancing the sheath into the tissue towards the surgical site. Thetissue separation tip is arranged to form a tissue gap and provide theat least one surgical instrument access to the tissue gap for performinga medical procedure consonant with the formation of the tissue gap orthe performance of work at the surgical site.

The tissue separation tip may comprise a plurality of fingers extendingfrom and hingedly coupled to the sheath distal portion and be arrangedto advance into the tissue when in a closed condition and to separatetissue to form the tissue gap when subsequently opened. The plurality offingers may comprise at least two fingers. The introducer may furthercomprise a control cable for opening the fingers. The introducer mayfurther comprise a control cable for closing the fingers. The introducermay further comprise an actuator associated with each finger, theactuators being operative individually or together for separate orconcurrent opening of the fingers. The actuators may be operative ingroups of two or more for opening different groups of the fingers bydifferent amounts. The introducer may further comprise webbing bridgingadjacent fingers to apply substantially uniform distributed pressure onthe separated tissue.

The tissue separation tip may include a plurality of inflatable memberswhich, when inflated, serve to separate the tissue and form the tissuegap. The introducer may further include at least one conduitcommunicating with the inflatable members for providing the inflatablemembers with an inflating fluid. The plurality of inflatable members maybe arranged for individual or concurrent inflation. The plurality ofinflatable members may be arranged for inflation of selected groups oftwo or more inflatable members.

The tissue separation tip may include a plurality of inflatable memberswhich, when inflated, serve to separate the tissue and form the tissuegap. The inflatable members may be deflatable and the tissue separationtip may further include a plurality of fingers extending from andhingedly coupled to the sheath distal portion arranged to open as theinflatable members are deflated for maintaining the tissue gap formed bythe inflatable members while also maintaining substantially constantpressure on the separated tissue. Each respective given one of theinflatable members may be carried by a respective given one of thefingers. The plurality of fingers may comprise at least two fingers andthe plurality of inflatable members may comprise a like plurality of atleast two inflatable members. The introducer may further comprise acontrol cable for opening the fingers. The introducer may furthercomprise a control cable for closing the fingers.

The introducer may further comprise a plurality of control cables. Thecontrol cables may be arranged for closing the fingers in selectablegroups of two or more for concurrent closing of selected groups offingers by differing amounts. The introducer may further comprise anactuator associated with each finger. The actuators may be operativeindividually or together for separate or concurrent opening of thefingers. The actuators may be operative in groups of two or more foropening different groups of the fingers by different amounts.

The introducer may further comprise webbing bridging adjacent fingers toapply uniform distributed pressure on the separated tissue. Theintroducer may further include at least one conduit communicating withthe inflatable members for providing the inflatable members with aninflating fluid. The plurality of inflatable members may be arranged forindividual or concurrent inflation or for inflation of selected groupsof two or more inflatable members.

According to further aspects of the invention, an introducer provides asurgical tool with a pathway through tissue to a surgical site. Thesurgical tool includes at least one surgical instrument. The introducercomprises a flexible sheath having a distal portion including a distalend and arranged for receiving the surgical tool.

The introducer further includes a tissue separation tip at the distalportion of the sheath for advancing the sheath into the tissue towardsthe surgical site. The tissue separation tip is arranged to form atissue gap and provide the at least one surgical instrument access tothe tissue gap for performing a medical procedure consonant with theformation of the tissue gap. The tissue separation tip includes aplurality of inflatable and deflatable balloons which, when inflated,serve to separate the tissue and form the tissue gap and a plurality offingers extending from and hingedly coupled to the sheath distal portioncarrying the balloons and arranged to open as the balloons are deflatedfor maintaining the tissue gap formed by the inflatable members whilealso maintaining substantially constant pressure on the separatedtissue.

According to further aspects of the invention, the invention provides amethod of introducing a surgical tool to a surgical site within tissue,wherein the surgical tool includes at least one surgical instrument. Themethod comprises providing an introducer comprising a flexible sheathhaving a distal portion including a distal end and arranged forreceiving the surgical tool and a tissue separation tip at the distalportion of the sheath, the tissue separation tip when in a firstconfiguration being adapted for advancing the tip through the tissue andwhen in a second configuration adapted for separating the tissue. Themethod further includes inserting the surgical tool into the introducersheath, advancing the tissue separation tip into the tissue with theseparation tip being in the first configuration, placing the separationtip in the second configuration to separate the tissue with theseparation tip to form a tissue gap, performing a medical procedure withthe at least one surgical instrument consonant with the formation of thetissue gap, returning the separation tip to the first configuration, andfurther advancing the tissue separation tip into the tissue with theseparation tip being in the first configuration.

The tissue separation tip may include a plurality of inflatable memberswhich, when inflated, serve to separate the tissue and form the tissuegap and the placing step may include inflating the inflatable members.The tissue separation tip may comprise a plurality of fingers extendingfrom and hingedly coupled to the sheath distal portion and the placingstep may include opening the fingers at the distal portion of thesheath.

The tissue separation tip may comprise a plurality of fingers extendingfrom and hingedly coupled to the sheath distal portion and a pluralityof inflatable members which, when inflated, serve to separate the tissueand form the tissue gap. The placing step may include first inflatingthe inflatable members and thereafter opening the fingers at the distalportion of the sheath while deflating the inflatable members.

The tissue separation tip may comprise a plurality of fingers extendingfrom and hingedly coupled to the sheath distal portion and a pluralityof inflatable members which, when inflated, serve to separate the tissueand form the tissue gap. The placing step may include first inflatingthe inflatable members and thereafter opening the fingers at the distalend of the sheath while deflating the inflatable members and maintainingsubstantially constant pressure on the separated tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further features and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like reference numerals identify identical elements, and wherein:

FIG. 1 is side view, with portions cut away, of an introducer deviceembodying the present invention in a first configuration of use;

FIG. 2 is an end view of the introducer of FIG. 1;

FIG. 3 is an end view showing an alternative embodiment of theintroducer device of FIG. 1;

FIG. 4 is a side view, with portions cut away, of the introducer deviceof FIG. 1 shown in a second configuration of use;

FIG. 5 is a side view, with portions cut away, of the introducer deviceof FIG. 1 shown in a third configuration of use;

FIG. 6 is a side view, with portions cut away, of the introducer deviceof FIG. 1 during the preparation for the performance of a medicalprocedure while the introducer device is in the third configuration ofuse;

FIG. 7 is a side view, with portions cut away, showing the performanceof a medical procedure while the introducer device of FIG. 1 is in thethird configuration of use;

FIG. 8 is side view, with portions cut away, of another introducerdevice embodying the present invention in a first configuration of use;

FIG. 9 is a side view, with portions cut away, of the introducer deviceof FIG. 8 shown in a second configuration of use;

FIG. 10 is a side view, with portions cut away, of the introducer deviceof FIG. 8 shown in a third configuration of use;

FIG. 11 is a simplified perspective view illustrating the manner inwhich the introducer devices may be configured for selective actuationin accordance with further aspects of the present invention;

FIG. 12 is a side view of a still another introducer device embodyingthe present invention; and

FIG. 13 is a perspective view showing details of the actuator 70 of theintroducer device of FIG. 10.

DETAILED DESCRIPTION

FIG. 1 is a side view of an introducer device 10 embodying the presentinvention. The introducer 10 generally includes a sheath 12 and a tissueseparation tip 14. The introducer has a proximal portion 16 and a distalportion 18 that includes the separation tip 14.

The sheath 12 is dimensioned for receiving a surgical tool 20 therein.The surgical tool may be, for example, the surgical device shown anddescribed in the aforementioned co-pending application Ser. No.12/943,745, filed Nov. 10, 2010, for SURGICAL DEVICE, which applicationis incorporated herein in its entirety. To that end, the surgical tool20 includes a sheath 22. At the distal end of the sheath 20 are toolsupports 24 and 26. The sheath 20 and supports 24 and 26 accommodatetool conduits 28 and 30. The conduits permits surgical instruments to beinserted into the tool 20 or removed there from during a medicalprocedure without requiring the entire tool 20 from being removed fromthe patient. As will be seen subsequently, as the introducer separatestissue to form tissue gaps, the surgical instruments may be advancedthrough the tool 20 and used to perform a medical procedure consonantwith the formation of the tissue gap. Such procedures may includevisualization, connective tissue cutting and cauterizing. Still further,once the surgical site is reached, the introducer may serve to maintainthe surgical site and permit performance of work at the surgical site.

The introducer 10 includes a plurality of fingers extending from thesheath 12 in the distal direction. The number of fingers employed in theintroducer may vary depending upon the circumstances. In accordance withthis embodiment, and may be seen in FIG. 2, the introducer 10 includesfour fingers, 40, 42, 44, and 46. The fingers are hingedly connected tothe distal portion 18 of the 12. Also, as may be seen in FIG. 3, theintroducer 100 there shown includes six fingers, fingers 102, 104, 106,108, 110, and 112.

The introducer 10 further comprises a like plurality of inflatablemembers or balloons 50, 52, 54, and 56. Each balloon is associated withand carried by one of the respective fingers 40, 42, 44, and 46. Each ofthe inflatable members or balloons has a conduit that provides it withinflating fluid. To that end, balloon 50 is associated with conduit 50a, balloon 52 is associated with conduit 52 a, balloon 54 is associatedwith conduit 54 a, and balloon 56 is associated with conduit 56 a. Allof the balloons may be inflated concurrently or in selectable groups.

The combination of the balloons and the fingers provides a positive butgentle separation of tissue during surgical tool advancement towards thesurgical site. As the balloons or selected balloons or balloon groupsare inflated, the tissue is first separated to form a tissue gap.Thereafter, selected fingers, selected groups of fingers, or all of thefingers are opened as the balloons are deflated. This maintains thetissue gap formed by the inflatable members while also maintainingsubstantially constant pressure on the separated tissue. The forgoing isillustrated in the follow sequence of FIGS. 4-7.

In use, the introducer 10 in a first configuration as shown in FIG. 1 isdeployed at an entry point. Then, the balloons 50, 52, 54, and 56 areinflated to gently displace and separate the tissue to form a tissue gapas shown in FIG. 4. The introducer is now in a second configuration.Next, as seen in FIG. 5, the fingers 40, 42, 44, and 46 are opened. Asthe fingers are opened, the balloons 50, 52, 54, and 56 are deflated. Asthe fingers are opened and the balloons are deflated, the tissue gap ismaintained while substantially constant pressure is maintained on theseparated tissue. The introducer is now in a third configuration of use.

With the introducer 10 in the third configuration of use, as seen inFIG. 5, it may be made ready for the performance of medical procedures.As seen in FIG. 5, the introducer, while in the third configuration ofuse, presents the separated tissue to one or more medical instruments tobe employed in procedures such as visualization, connective tissuecutting and cauterizing consonant with advancement of the introducer 10.FIGS. 6 and 7 illustrate the medical procedures being performed.

Once the tissue gap has been formed and the medical procedures arecompleted, the process returns to placing the introducer back into thefirst configuration as shown in FIG. 1. The separation tip 14 may thenbe advanced and the foregoing procedure repeated until the surgical siteis reached. Once the surgical site is reached, the introducer may beused to maintain the surgical site for the physician during the primarymedical procedure.

Referring now to FIGS. 8-10, they show the distal portions of anotherintroducer device embodying the invention. The introducer 60 includes asheath 62 and a tissue separation tip 64. The tissue separation tip 64includes a plurality of fingers, two of which are shown at 66 and 68. Asin the previous embodiment, the device may have two or more fingers. Insome embodiments, the device may have four fingers, in other embodimentssix, and in other embodiments even a greater number of fingers. FIG. 8shows the introducer in the first, closed, configuration. Each finger isassociated with an actuator for opening the finger. In FIG. 8, forexample, finger 66 is associated with actuator 70 and finger 68 isassociated with actuator 72. The actuators are hingedly carried on thesheath in the distal portion of the sheath 62. As may be noted in FIG.8, finger 66 is connected to the sheath distal portion by a hinge 74 andfinger 68 is connected to the sheath distal portion by a hinge 76. Themanner in which the actuators open the fingers will be described indetail subsequently. The introducer 60, when in the first configurationas shown in FIG. 8 is ready to be placed at an entry site or to beadvance further into tissue.

As in the previous embodiment, the introducer 60 further includes aplurality of inflatable members. In accordance with this embodiment,each finger is associated with and carries an inflatable member. To thatend, finger 66 carries inflatable member 78 and finger 68 carriesinflatable member 80. FIG. 9 shows the introducer 60 in the secondconfiguration with the inflatable members 78 and 80 inflated. As in theprevious embodiment, as the inflatable members are inflated, adjacenttissue is gently separated or displaced. Each inflatable member 78 and80 is associated with a conduit 82 and 84 respectively. The conduitspermit the inflatable members to be filled with an inflating fluid, suchas saline. The conduits may be arranged to inflate each inflatablemember individually, or arranged to inflate the conduits in selectivegroups. The inflatable members or groups of inflatable members may beinflated concurrently or in any desired order or as required.

FIG. 10 shows the introducer 60 in its open or third configuration. Toopen each finger, each finger is associated with an actuator. Finger 66is associated with actuator 70 and finger 68 is associated with actuator72. As previously mentioned, the fingers are each hingedly connected tothe sheath 62. Actuator 70 causes finger 66 to open about hinge 74 andactuator 72 causes finger 68 to open about hinge 76. Each actuatorincludes a spring member that acts upon its respective finger to openthe finger. Actuator 70 includes spring member 86 and actuator 72includes spring member 88. The springs are biased to maintain contactwith its finger. However, when the ends of the spring members are pulledback, the springs bow. This forces the fingers to open. Morespecifically, spring member 86 is connected to a control cable 90 andspring member 88 is connected to a control cable 92. Control cable 90 isshown in greater detail in FIG. 13. Here, it may be seen that the cable90 loops around the spring member 86 and is once again connected toitself. When the cables 90 and 92 are pulled in direction of arrow 94,the spring members 86 and 88 bow out and push on their respective finger66 and 68. As a result, fingers 66 and 68 are opened.

The spring members may be acted upon by the control cables concurrentlyfor concurrently opening the fingers. Also, the spring members may beacted upon by the control cables individually in any desired or requiredorder to open individual fingers completely or by varying amounts.Alternatively, the spring members may be acted upon to open the fingersin groups. This is shown, for example in FIG. 11. In this simplifieddrawing, the spring members are arranged in groups, group 120 and group122. Group 120 includes spring members 124 and 126. Group 122 includesspring members 128 and 130. The springs of the spring member groups areconnected together by a common connector. Common connector 132 isconnected to spring members 124 and 126 and common connector 134 isconnected to spring members 128 and 130. Each connector is connected toa control cable. Connector 132 is connected to control cable 136 andconnector 134 is connected to control cable 138. When the control cablesare pulled in the direction of arrows 140, the spring members of eachgroup are bowed together, causing the respective fingers to opentogether. Hence, the pulling of control cable 136 bows spring members124 and 126 together and the pulling of control cable 138 causes springmembers 128 and 130 to bow together. The groups of fingers may be openedconcurrently or in a sequence as desired or required.

Returning now to FIG. 10, each of the fingers 66 and 68 is associatedwith a retraction cable 96 and 98. The retraction cable may be employed,if necessary, to close the fingers 66 and 68 respectively. In actualpractice, the fingers may be closed by the force of tissue. However,when needed, the retraction cables 96 and 98 may be relied upon to closetheir respective fingers.

As in the previous embodiment, it is contemplated that as each finger 66and 68 is opened, the corresponding inflatable member or balloon 78 and80 is deflated. The deflation of the balloons as the fingers open servesto maintain the tissue separation or tissue gap while also maintaining asubstantially constant pressure on the separated tissue.

The introducer 60 as shown in FIG. 10 presents the tissue gap orsurgical site to the one or more instruments that may be received by thesheath 62. The device as described in the aforementioned co-pendingapplication is preferably received by the sheath 62 and used to steerthe introducer. Hence while the surgical device within the sheathperforms the steering function, the introducer enabled the advancementof the assembly.

Referring now to FIG. 12, it shows another introducer device embodyingthe invention. The device 150 includes a sheath 152 and a tissueseparation tip 154. As in the previous embodiments, the tissueseparation tip includes a plurality of fingers 156 and a like pluralityof inflatable members 158 carried by the fingers 158. Between thefingers 158 is a web 160. The web provides substantially uniform supportfor the separated tissue when the introducer is in the thirdconfiguration of FIG. 10. As may be appreciated by those skilled in theart, the web may also be employed in the embodiments of FIGS. 8-11 forproviding substantially uniform support for the separated tissue.Further, the embodiments of FIGS. 1-7 may also include control cablesfor opening and closing the fingers. The control cables may extendproximally along the introducer sheath in a manner similar to thecontrol cables of the surgical device of co-pending application Ser. No.12/943,745, for connection to a control assembly.

In each embodiment disclosed herein, the sheath may be compositelyformed of one or more flexible materials such as, for example, PVDF(polyvinylidene fluoride), Nylon (Polyamide), Polyethylene terephthalate(PET), or polycarbonate. Similarly, the fingers and actuators may becompositely formed of one or more flexible material such as, forexample, Nitinol (Nickel Titanium), spring steel, stainless steel,titanium, PVDF (polyvinylidene fluoride), Nylon (Polyamide),Polyethylene terephthalate (PET), or polycarbonate. Such materials arewell known in the art.

While a particular embodiment of the invention has been shown anddescribed, changes and modifications may be made. It is thereforeintended to cover in the appended claims all such changes andmodifications which fall within the true spirit and scope of theinvention.

What is claimed is:
 1. A method of providing a tissue gap configured toprovide access for a surgical tool to a surgical site within tissue, themethod comprising: providing an introducer comprising a flexible sheathand a tissue separation tip disposed at a distal portion of the flexiblesheath; advancing the tissue separation tip through tissue with thetissue separation tip in a first configuration adapted for saidadvancing; inflating one or more inflatable members carried bydisplaceable fingers of the tissue separation tip to form a tissue gap;and opening the fingers while deflating the inflatable members such thata tissue gap is maintained.
 2. The method of claim 1, furthercomprising: inserting the surgical tool into the introducer sheath; andadvancing the surgical tool through the introducer sheath and the tissueseparation tip.
 3. The method of claim 1, further comprising: returningthe tissue separation tip to the first configuration; and furtheradvancing the tissue separation tip into the tissue with the separationtip in the first configuration.
 4. The method of claim 3, whereinreturning the tissue separation tip to the first configuration comprisesdisplacing one or more retraction cables drivingly coupled with thefingers.
 5. The method of claim 1, wherein said advancing the tissueseparation tip through tissue comprises advancing the tissue separationtip through a body lumen.
 6. The method of claim 1, wherein the fingersare oriented substantially parallel to a distal portion of the sheathwhen opened.
 7. The method of claim 1, wherein each of the fingerscarries a respective one of the inflatable members.
 8. The method ofclaim 1, wherein each of the displaceable fingers extends from and ishingedly coupled with a distal portion of the sheath.
 9. The method ofclaim 8, wherein opening the displaceable fingers comprises displacingone or more control cables drivingly coupled with the fingers.
 10. Themethod of claim 9, wherein displacing the one or more control cablesreconfigures one or more actuators drivingly coupled with the fingers.11. The method of claim 10, wherein the one or more actuators comprise aspring member coupled with one of the control cables, and displacing ofthe coupled control cable deforms the spring member so as to push one ofthe fingers open.
 12. The method of claim 10, wherein the one or moreactuators comprise an actuator associated with each finger, the one ormore actuators being configured such that each finger can be openedindividually.
 13. The method of claim 10, wherein the one or moreactuators comprise an actuator associated with each finger, the one ormore actuators being configured such that the fingers are openedconcurrently.
 14. The method of claim 10, wherein the one or moreactuators comprise an actuator associated with each finger, the one ormore actuators being operative in groups of two or more for openingdifferent groups of the fingers by different amounts.
 15. The method ofclaim 1, wherein the fingers comprise four fingers.
 16. The method ofclaim 15, wherein the fingers comprise six fingers.
 17. The method ofclaim 1, wherein webbing bridges adjacent fingers so that the webbingapplies pressure to the separated tissue.
 18. The method of claim 1,wherein each of the inflatable members is individually inflated.
 19. Themethod of claim 1, wherein each of the inflatable members isconcurrently inflated.
 20. The method of claim 1, wherein each of atleast two selected groups of two or more of the inflatable members areseparately inflated.